Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves
K171279 is the FDA 510(k) clearance record for Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves, a class I device, cleared for Top Glove Sdn. Bhd. on under FDA product code KGO (Surgeon'S Gloves). FDA's definition for product code KGO reads: "A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a...". FDA records list 17 510(k) clearances for Top Glove Sdn. Bhd., from to . As of , FDA records show no recalls naming K171279.
Clearance record
- Decision date
- Received
- (164 days to decision)
- Product code
- KGO Surgeon'S Gloves
- Regulation
- 21 CFR 878.4460
- Device class
- Class I
- Review panel
- General, Plastic Surgery
- Applicant
- Top Glove Sdn. Bhd. Lot 4968, Jalan Teratai, Batu 6, Klang, MY
- 510(k) summary
- Statement
- Third party review
- No
Clearances, product code KGO
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 0 |
| May 2026 | 1 |
| June 2026 | 0 |
| July 2026 | 1 |
| August 2026 | 0 |
| September 2026 | 0 |
| October 2026 | 0 |
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